COOPERATIVE PROGRAM ON RETINAL DEGENERATIVE DISEASE RESEARCH
Release Date: November 10, 1999
PA NUMBER: PA-00-009
National Eye Institute
THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.
PURPOSE
The National Eye Institute (NEI) and the Foundation Fighting Blindness (FFB)
announce a cooperative program of research support on retinal degenerative
diseases. This program announcement (PA) signals the interest of NEI and FFB
in funding grant applications that meet the programmatic interests of the NEI
and FFB in the area of retinal degenerative diseases. The PA is intended to
stimulate basic cellular, molecular, genetic, and clinical research on
retinal degenerative diseases. Applications in response to this PA will use
the following grant mechanisms: research project grant (R01), Small Business
Technology Transfer Grants (STTR) (R41 and R42), Small Business Innovation
Research Grants (SBIR) (R43 and R44), Mentored Clinical Scientist Development
Award (K08), Mentored Patient-Oriented Research Career Development Award
(K23), and Midcareer Investigator Award in Patient-Oriented Research (K24).
Each of these mechanisms vary in eligibility, applications procedures, review
criteria, etc. Pay particular attention to the variances in the mechanisms
when applying under this PA.
HEALTHY PEOPLE 2000
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2000", a PHS
led national activity for setting priority areas. This PA, Cooperative
Program for Research on Retinal Degenerative Diseases, is related to one or
more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000.
RESEARCH PROJECT GRANTS (R01)
A. ELIGIBILITY REQUIREMENTS
Applications for R01 grants may be submitted by domestic and foreign, for-
profit and non-profit organizations, public and private, such as
universities, colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government. Racial/ethnic
minority individuals, women, and persons with disabilities are encouraged to
apply as Principal Investigators.
MECHANISM OF SUPPORT
Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant. The total project period for
an application submitted in response to this PA may not exceed five years.
Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
https://grants.nih.gov/grants/funding/modular/modular.htm.
B. SMALL BUSINESS GRANTS (R41, R42, R43, R44)
ELIGIBILITY
Eligibility requirements for applications for Phase I STTR grants (R41) are
described in the Omnibus Solicitation of the National Institutes of Health
for STTR Grant Applications (PHS 99-3), which is available at
https://grants.nih.gov/grants/funding/sttr1/toc.htm . Eligibility
requirements for applications for Phase II STTR grants (R42) are described in
the grant application kit PHS Form 6246-4, which is available at
https://grants.nih.gov/grants/funding/sttr2/index.html . All instructions and
information in these documents also apply to applications submitted in
response to this PA.
Eligibility requirements for applications for Phase I SBIR grants (R43) are
described in the Omnibus Solicitation of the National Institutes of Health,
Centers for Disease Control and Prevention, and Food and Drug Administration
for SBIR Grant Applications (PHS 99-2). This Solicitation is available at
https://grants.nih.gov/grants/funding/sbir1/toc.htm . Eligibility
requirements for applications for Phase II SBIR grants (R44) are described in
the grant application kit PHS Form 6246-2, which is available at
https://grants.nih.gov/grants/funding/sbir2/index.htm . All instructions and
information in these document also apply to applications submitted in
response to this PA. Racial/ethnic minority individuals, women, and persons
with disabilities are encouraged to apply as Principal Investigators.
MECHANISM OF SUPPORT
Responsibility for the planning, direction, and execution of the proposed
research will be solely that of the applicant. Phase II SBIR and STTR
applications in response to this PA will only be accepted as competing
continuations of previously funded NIH Phase I SBIR or STTR awards. The
previously funded Phase I award need not have been awarded under this PA but
the Phase II proposal must be a logical extension of the Phase I research.
The Fast Track initiative (described in the SBIR and STTR Omnibus
Solicitations) is designed to expedite the decision and award of SBIR and
STTR Phase II funding for scientifically meritorious applications for
projects that have a high potential for commercialization. Fast Track is a
parallel review option available to those small business concerns whose
applications satisfy additional criteria which enhance the probability of the
project's commercial success. Those criteria are described in the Omnibus
Solicitations. Applications that do not meet these criteria may be
redirected for review through the standard review procedures described in the
Omnibus Solicitations. Fast Track offers two major advantages: 1) concurrent
submission and peer review of both Phase I and Phase II projects and 2)
minimal or no funding gap between Phase I and Phase II.
C. RESEARCH CAREER DEVELOPMENT AWARDS (K08, K23, K24)
ELIGIBILITY
Eligibility requirements for applications for Mentored Clinical Scientist
Development Awards (K08) are described at
https://grants.nih.gov/grants/guide/pa-files/PA-00-003.html . Eligibility
requirements for applications for Mentored Patient-Oriented Research Career
Development Awards (K23) are described at
https://grants.nih.gov/grants/guide/pa-files/PA-00-004.html . And eligibility
requirements for Midcareer Investigator Awards in Patient-Oriented Research
(K24) are described at https://grants.nih.gov/grants/guide/pa-files/PA-00-005.html.
NEI-specific supplemental information regarding these awards is
available at http://www.nei.nih.gov/funding/NEIFM.htm .
MECHANISM OF SUPPORT
Responsibility for the planning, direction, and execution of the proposed
research will be solely that of the candidate on behalf of the applicant
organization. The total project period for an application submitted in
response to this PA may be three, four, or five years. K08 and K23 career
development awards are not renewable; the K24 award may be renewable for one
additional five-year period if the candidate still meets the stated
requirements.
Candidates for career development awards should consult the NIH website for
details: https://grants.nih.gov/training/careerdevelopmentawards.htm.
RESEARCH OBJECTIVES
Background
Retinal degenerative diseases including retinitis pigmentosa (RP), Usher's
syndrome, macular degeneration, and other rare disease forms affect over six
million Americans. These blinding diseases affect persons of all ages and
races. During the past decade, dramatic progress had been made in
understanding many aspects of retinal degenerative diseases through studies
of the structure, function, and metabolism of the normal retina and retinal
pigment epithelium (RPE). In particular, the application of molecular
techniques has allowed the identification of many genes responsible for a
number of retinal degenerative diseases. The identified human gene mutation
has allowed scientists to identify or create animal models with retinal
degeneration. In addition, genes responsible for retinal degeneration in
naturally-arising RD and RDS mouse strains are now known to be homologous to
genes associated with retinal degenerative diseases in humans. All these
animal models are the subject of intensive study to determine the
pathophysiological mechanisms by which gene defects lead to photoreceptor
degeneration.
New knowledge about molecular defects underlying inherited blindness in
animals and humans has shown that retinal degenerations are a highly
heterogeneous group of diseases. Yet, studies from many laboratories have
defined several promising new therapeutic approaches. Progress has been made
in gene targeting approaches with the development of a new generation of
vectors, which may be more effective and safe. In addition, several
laboratories have shown slowing of photoreceptor degeneration in several
animal models following therapy with neuronal survival factors or growth
factors. Retinal transplantation has seen some advances, but there is a need
for better understanding of the immunological issues related to
transplantation into the subretinal space. Scientists are also exploring
other approaches that may be potentially useful in treatment of retinal
degenerative diseases. These include studies of anti-apoptotic proteins as
potential therapeutic agents as well as ribozymes, antisense nucleic acids,
and triplex-forming oligonucleotides. Identifying the underlying molecular
and cellular defects in retinal degenerative diseases will be critical to the
development of effective therapies to slow or halt the degenerative process.
Research Topics
It is the intent of this solicitation to invite applications from
investigators with diverse scientific interests to enhance our understanding
of the etiology and pathogenesis of retinal degenerative diseases, and to
develop innovative strategies to prevent, treat, or cure these blinding
diseases. It is hoped that applicants will capitalize on recent and emerging
research progress and research tools. Broad areas of interest related to the
goals of this PA include, but are not limited to:
o Identify novel causes of retinal degenerative diseases; examine the
cellular and molecular mechanisms whereby gene defects cause retinal
degenerations.
o Further delineate the pathophysiology of human retinal degenerative
disease
o Identify additional genes and modifiers involved in retinal degenerative
diseases.
o Develop and critically evaluate potential therapeutic strategies, such as
gene transfer, tissue and cell transplantation, growth factor therapy, and
pharmacological intervention. Identify innovative therapeutic interventions
and gene-targeted approaches to slow or prevent the progression of retinal
degeneration.
o Identify retinal genes and expressed sequence tags (ESTs) that are unique
to the visual system or that have hall marks of candidates for retinal
degenerative diseases.
o Understand the normal function of the retina and RPE and apply this
knowledge to the treatment, prevention, and diagnosis of retinal degenerative
diseases.
o Identify genes, pathways, and factors important for retina development,
especially those that may be involved in controlling cell fate determination
and differentiation.
o Investigate the regenerative capacity of the retina.
o Improve neuroprotective strategies that could prevent retinal cell death,
promote survival, or stimulate regeneration.
o Develop improved methods for clinical diagnosis of retinal degenerative
diseases and for monitoring progression of the disease and treatment
effectiveness.
Information regarding NEI programmatic interest in retinal degenerative
diseases is available in NEI's publication, Vision Research--A National Plan:
1999-2003, which is located at
http://www.nei.nih.gov/resources/strategicplans/plan.htm.
FFB Mission Statement: The mission of the FFB is to discover the causes,
treatments, preventions, and cures for retinitis pigmentosa, macular
degeneration, Usher's syndrome, and other related retinal degenerative
diseases. More information regarding the Foundation and its programmatic
interests can be found at http://www.blindness.org.
SPECIAL REQUIREMENTS
The NEI and FFB plan to sponsor periodic meetings to facilitate exchange of
information among investigators funded as a result of this initiative and to
foster cooperation and collaborative efforts among investigators. For this
purpose, requests for travel funds for a one-day meeting each year in
Bethesda, Maryland, should be included in the budget.
In order for an application to be considered for funding by the FFB, the
applicant must submit a brief letter of authorization, co-signed by the
Principal Investigator and the official signing for the applicant
institution, authorizing the NEI to release the application, the summary
statement and all related materials to the FFB. These materials will be
shared with the FFB when available. Applications without such authorization
will not be considered for funding by the FFB.
Dissemination of Research Resources
It is anticipated that research developed under this PA will generate
reagents such as cDNA libraries, ESTs, clones, and sequences. The sharing of
such materials, data, and software in a timely manner has been an essential
element in the rapid progress that has been made in biomedical research.
Research materials and results produced in projects funded by this PA will be
distributed to scientific investigators in the wider research community, and
will augment existing resources. PHS policy requires that investigators make
unique research resources readily available for research purposes to
qualified individuals within the scientific community, see
https://grants.nih.gov/grants/guide/notice-files/not96-184.html
.
The NIH is interested in ensuring that the research resources developed
through this PA become readily available to the research community for
further research, development, and application, in the expectation that this
will lead to products and knowledge of benefit to the public. For this
reason, NIH is concerned that patent applications for a large number of ESTs,
cDNAs, and other research resources might have a chilling effect on the
future development of products and information that may improve the public
health. At the same time, NIH recognizes the rights of grantees to elect and
retain title to subject inventions developed under Federal funding under the
provision of the Bayh-Dole Act. Indeed for inventions developed in its
intramural program, NIH does file patent applications, in accord with a set
of policies described at http://ott.od.nih.gov/phspat_policy.html.
To address the joint interests of the government in the availability of, and
access to, the results of publicly-funded research and in the opportunity for
economic development based on these results, NIH requires applicants who
respond to this PA to propose detailed plans for sharing the research
resources and data generated through the grant, if applicable. For this
purpose, it is the opinion of the NIH that dissemination of such developments
via individual laboratory web sites is not sufficient, as it would force
interested investigators to have to search several different data collections
to make use of the results of this initiative. Specifically, applicants
should (1) propose a plan for placing clones, ESTs, and other research
resources in common, public databases and repositories, and (2) address if or
how they plan to exercise their intellectual property rights, including
options to for-profit research sponsors, that might be associated with
clones, ESTs, and cDNA libraries that may be generated.
It is expected that the investigator's data sharing plan include all elements
of the guidelines developed by the NIH and the Department of Energy to
address the special needs of human genome research. These guidelines call
for material and information to be made available within six months of the
time the data or materials are collected, and are available at
http://www.nhgri.nih.gov/Grant_info/Funding/Statements/data_release.html
Adherence with this time frame is highly desirable. More rapid sharing is
encouraged. Requests for exemptions or extensions will require compelling
justification and will be fully evaluated by program staff.
Applicants are also reminded that the grantee institution is required to
disclose each subject invention to the Federal agency providing research
funds within two months after the inventor discloses it in writing to grantee
institution personnel responsible for patent matters. The NEI reserves the
right to monitor grantee activity in this area to ascertain if patents on
large numbers of research resources related to this PA are being filed.
Where appropriate, grantees may work with the private sector to make unique
resources available to the wider biomedical research community at a
reasonable costs. Applicants may request funds to defray the costs of
sharing resources, with adequate justification.
INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification is provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing research involving human subjects should read the
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research," which has been published in the Federal Register of March 28, 1994
(FR 59 14508-14513) and in the NIH Guide to Grants and Contracts, March 18,
1994, available on the web at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not94-100.html.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
It is the policy of the NIH that children (individuals under the age of 21)
must be included in all research involving human subjects conducted or
supported by the NIH, unless there are scientific or ethical reasons not to
include them. This policy applies to all initial (Type 1) applications
submitted for receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and contracts, March 6, 1998, and is available at the following URL
address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html .
Investigators may also obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
APPLICATION PROCEDURES
A. RESEARCH PROJECT GRANTS (R01)
Applications for R01 grants are to be submitted on the grant application form
PHS 398 (rev. 4/98). All submissions will be accepted at the standard
application deadlines as indicated in the application kit. Application kits
are available at most institutional offices of sponsored research and may be
obtained from the Division of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD
20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov.
Applicants planning to submit a grant application requesting $500,000 or more
in direct costs for any year are required to discuss their eligibility with
the NEI program staff contact listed at the end of this program announcement
before submitting the application. Furthermore, the applicant must obtain
agreement from NEI program staff that the NEI will accept the application for
consideration of award. Finally, the applicant must identify, in a cover
letter sent with the application, the program staff member who agreed to
accept assignment of the application. This policy requires an applicant to
obtain agreement for acceptance of both any such application and any
subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March
20, 1998, which is available at
https://grants.nih.gov/grants/guide/notice-files/not98-030.html
The title and number of this Program Announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The
just-in-time concept allows applicants to submit certain information only
when there is a possibility for an award. It is anticipated that these
changes will reduce the administrative burden for the applicants, reviewers
and Institute staff. The research grant application form PHS 398 (rev. 4/98)
is to be used in applying for these grants, with the modifications noted
below.
BUDGET INSTRUCTIONS
Modular Grant applications will request direct costs in $25,000 modules, up
to a total direct cost request of $250,000 per year. (Applications that
request more than $250,000 Direct Costs in any year must follow the
traditional PHS 398 application instructions.) The Total Direct Costs must
be requested in accordance with the program guidelines and the modifications
made to the standard PHS 398 application instructions described below:
PHS 398
o FACE PAGE: - Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular
Total Direct plus Facilities and Administrative (F&A) Costs] for the initial
budget period. Items 8a and 8b should be completed indicating the Direct and
Total Costs for the entire proposed period of support.
o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.
o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.
o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs requested
for each year. This is not a Form Page.
o PERSONNEL - List key project personnel, including their names, percent of
effort, and roles on the project. No individual salary information should be
provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.
o CONSORTIUM/CONTRACTUAL COSTS - Provide an estimate of Total Costs (Direct
plus F&A Costs) for each year, each rounded to the nearest $1,000. List the
individuals/organizations with whom consortium or contractual arrangements
have been made, the percent effort of key personnel, and their role on the
project. Indicate whether the collaborating institution is foreign or
domestic. The Total Cost for a consortium/contractual arrangement is
included in the overall requested Modular Direct Cost amount. Include the
Letter of Intent to establish a consortium.
o Provide an additional narrative budget justification for any variation in
the number of modules requested.
o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three
pages may be used for each person. A sample biographical sketch may be
viewed at: https://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.
o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied
in the calculation of the F&A Costs for the initial budget period and all
future budget years.
o The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.
Submit a signed, typewritten original of the application, including the
Checklist, and five signed photocopies in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
B. SMALL BUSINESS GRANTS (R41, R42, R43, R44)
Applications for SBIR or STTR Phase I, Phase II, or Fast Track grants are to
be submitted on the grant application forms in the Omnibus Solicitations
described above. Applications will be accepted on or before the receipt
dates indicated in the application kits. The Omnibus Solicitations are
available on the Internet at https://grants.nih.gov/grants/funding/sbir.htm .
A limited number of hard copies of the Omnibus Solicitation are available
from: PHS SBIR/STTR Solicitation Office, 13685 Baltimore Avenue, Laurel, MD
20707-5096, telephone 301/206-9385, FAX 301/206-9722, Email a2y@cu.nih.gov .
Submit a signed, typewritten original of the application, including the
checklist, and two signed photocopies in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
C. RESEARCH CAREER DEVELOPMENT AWARDS (K08, K23, K24)
Potential candidates are strongly encouraged to contact an NEI staff person
listed under INQUIRIES. Such contact should occur early in the planning
phase of application preparation. Such contact will help ensure that
applications are responsive to the goals and policies of the NEI.
Applicants who will be using a General Clinical Research Center (GCRC) are
requested to include a letter from either the GCRC Program Director or the
Principal Investigator with the application.
Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) using the instructions in Section IV and the NEI-specific instructions
at http://www.nei.nih.gov/funding/NEIFM.htm as appropriate. Applications
will be accepted on or before the receipt dates indicated in the application
kit. Forms are available at most institutional offices of sponsored research
and from the Division of Extramural Outreach and Information Resources,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD
20892-7910, Phone (301) 435-480-0525, Email: grantsinfo@nih.gov. Forms are
also available on the NIH website at https://grants.nih.gov/grants/forms.htm.
Submit a signed, typewritten original of the application, including the
checklist, and five signed photocopies in one package to:
CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710
BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical
merit by an appropriate scientific review group convened in accordance with
the standard NIH peer review procedures. As part of the initial merit
review, all applications will receive a written critique and undergo a
process in which only those applications deemed to have the highest
scientific merit, generally the top half of applications under review, will
be discussed and assigned a priority score. All applications will receive a
second level review by the appropriate National Advisory Council.
Review Criteria
A. RESEARCH PROJECT GRANTS (R01)
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score weighting them as appropriate for each application. Note that
the application does not need to be strong in all categories to be judged
likely to have a major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field
forward.
1. Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
2. Approach: Are the conceptual framework, design, methods, and analyzes
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
3. Innovation: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
4. Investigator: is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
5. Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
B. SMALL BUSINESS GRANTS (R41, R42, R43, R44)
SBIR and STTR application review criteria are described in the Omnibus
Solicitations. Phase I applications should specify clear, measurable goals
(milestones) that should be achieved prior to initiating Phase II. Failure
to provide clear, measurable goals may be sufficient reason for the study
section to judge the application non-competitive.
C. RESEARCH CAREER DEVELOPMENT AWARDS (K08, K23, K24)
Mentored Clinical Scientist Development Award (K08) applications will be
reviewed according to the criteria described in
https://grants.nih.gov/grants/guide/pa-files/PA-00-003.html. Mentored
Patient-Oriented Research Career Development Award (K23) applications will be
reviewed according to criteria described in
https://grants.nih.gov/grants/guide/pa-files/PA-00-004.html. Midcareer
Investigator Award in Patient-Oriented Research (K24) applications will be
reviewed according to criteria described in
https://grants.nih.gov/grants/guide/pa-files/PA-00-005.html.
In addition to the above review criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.
AWARD CRITERIA
Applications will compete for available funds with all other recommended
applications. The following will be considered in making funding decisions:
Quality of the proposed project as determined by peer review, adequacy of
plans to make research resources developed during this project publicly
available in a timely manner, cost effectiveness of the proposed strategy,
promise of the proposed program to accomplish the goals of this PA, and
availability of funds.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Peter A. Dudley, Ph.D. or Maria Y. Giovanni, Ph.D.
Division of Extramural Research
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-0484
FAX: (301) 402-0528
Email: pad@nei.nih.gov or giovanni@nei.nih.gov
Santa J. Tumminia, Ph.D.
Science Programs Manager
The Foundation Fighting Blindness
Executive Plaza I, Suite 800
11350 McCormick Rd.
Hunt Valley, MD 21031-1014
Telephone: (410) 785-1414
FAX: (410) 771-9470
Email: stumminia@blindness.org
Direct inquiries regarding fiscal matters to:
William W. Darby
Grants Management Officer
Grants Management Branch
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda, MD 20892-7164
Telephone: (301) 496-5884
FAX: (301) 496-9997
Email: wwd@nei.nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance No.
93.867, Vision Research. Awards are made under authorization of the Public
Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public
Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies
and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program
is not subject to the intergovernmental review requirements of Executive
Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant and contract recipients to provide a
smoke-free workplace and promote the non-use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking
in certain facilities (or in some cases, a portion of a facility) in which
regular or routine education, library, day care, health care or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.